Secukinumab treatment of plaque psoriasis shows early improvement in DLQI response - results of a phase II regimen-finding trial

Abstract

Background: The social stigma and chronicity of psoriasis significantly affect health-related quality of life (HRQoL).

Objective: We examined the effect of three regimens of secukinumab on HRQoL in moderate to severe psoriasis patients.

Methods: Twelve-week data from a phase II, randomized, double-blind, placebo-controlled, regimen-finding study evaluated HRQoL, measured by the Dermatology Life Quality Index (DLQI). Secukinumab or placebo was administered subcutaneously in three treatment regimens: single (baseline only), monthly (baseline, weeks 4, 8) and early (baseline, weeks 1, 2, 4). Differences among regimens were assessed with logistic regression models and Fisher's exact test.

Results: Patients (n = 404) were randomized to single (baseline) treatment regimen, n = 66; monthly, (baseline, weeks 4 and 8), n = 138; early, (baseline, weeks 1, 2, 4), n = 133; and placebo, n = 67. DLQI response was significantly higher in early, monthly and single regimens than in placebo regimen (40.8%, 33.6% and 13.1% vs. 1.6%, respectively; P < 0.001 for all).

Conclusion: Moderate to severe psoriasis patients receiving monthly and early treatment with secukinumab demonstrated improved HRQoL compared with placebo.

Figure 1

Plaque Psoriasis. Percentages of Patients Achieving DLQI Total Score of 0 or 1 at Baseline and at Weeks 4 and 12, by Treatment Regimen DLQI = Dermatology Life Quality Index. * P < 0.001 for difference of active treatment regimen to placebo. note: Patients with DLQI score of ≤ 1 were assessed as responders to treatment. Patients in the early and monthly regimens showed significant improvement in response when compared with patients in the placebo regimen.